WO2011072736A1

WO2011072736A1 - Device for tissue damage protection during child delivery

Info

Publication number: WO2011072736A1
Application number: PCT/EP2009/067315
Authority: WO
Inventors: Knut Hadeem
Original assignee: Vernix Pharma A/S
Priority date: 2009-12-16
Filing date: 2009-12-16
Publication date: 2011-06-23

Abstract

The present invention provides a device that protects the tissue in the posterior part of the introitus vagina, i.e. the commissura posterior. The origin of perineal tear starts here when the segment is stretched to double or triple its length during delivery of the head. Tears can be more extensive into the perineal body, continue into the anal sphincter and in worse cases even through the whole perineum into the anal canal. In use the device may protect against perineal tears of the posterior vaginal wall into the mucosa, perineal skin, muscles, even more profound down to the anal sphincter muscle and into the rectum and the rectal mucosa.

Description

DEVICE FOR TISSUE DAMAGE PROTECTION DURING CHILD DELIVERY

Field of the Invention

This invention pertains in general to the field of child delivery. More particularly the invention relates a device for protecting against tissue damage or tissue rupture during child delivery.

Background of the Invention

Perineal tears causes much discomfort among women post partum, but even long term ailments can occur. Lacerations involving the anal sphincter function and anal canal are looked upon as more serious than the ones involving the mucosa and perineal body only, however all kinds of rupture give discomfort.

Usually the direction of the tears is backwards from the posterior part of the vaginal opening called the commissura posterior with direction against the anal opening. If the rupture is only superficial it is called degree I, when it is deeper degree II. In case when the anal sphincter is involved degree III and when it is all through the anal canal it is IV. The delivery tears usually occur when the foetal head passes through the vaginal opening called the introitus vagina. The symptoms that follow afterwards are pain and swelling that gives raise too much discomfort immediately and weeks afterwards. In case the rupture extends into the anal sphincter muscle i.e. degree III and IV, anal incontinence frequently occur, mainly gas incontinence but even regular faecal incontinence. The frequency of these symptoms among the women is between 30 % and 50 %. The frequency has increased the last two decades, probably due to the fact that the mean weight of the baby has increased from 3300 to 3600 grams. Scientific studies have shown that weight of the baby correlates with number of tears i.e. the higher the weight is the higher probability for tears. The frequency of anal sphincter tears during delivery is a quality parameter of the delivery ward. Good delivery ward is related to low frequencies of sphincter tears. Effort is therefore continuously taken to lower the number of tears and especially avoid the extensive ones going into the rectum (degree IV), since it may cause future problems.

The more extensive the rupture, the more troublesome are the complaints afterwards. Especially ruptures involving the anal sphincter muscles (degree IV) have been studied, since the frequency have increased the last two decades from 0.6 % to approximately 4 to 8 % varying between different obstetric departments. The long-term results of women with earlier anal sphincter ruptures having unfortunately shown that many are still suffering of anal sphincter incompetence. 50 % of these women have persisting complaints with gas incontinence but also incontinence of liquid stool and in worst cases even formed stool.

WO 20071131109 A2 discloses a perianal support device that is configured to inhibit the formation and/or progression of tissue damage in the perianal region of the body. WO 20071131109 A2 also discloses a method to apply the perianal support device to patients during childbirth to inhibit the formation and/or progression of tissue damage in the perianal region of the body. The device disclosed in WO 20071131109 A2 comprises a construction having a rigid part (330, 340) intended to be in connection with the perianal region. Thus, the tissue in contact with the device is formed in accordance with the device by the pressure applied by the device. A further problem with the device of WO 20071131109 A2 is that it does not reduce the risk of tissue ruptures originating from the posterior vaginal area, such as the lowest portion 9 of the vaginal opening, as it only protects the perianal area close to the anal sphincter.

Moreover, the rigidness of the device provides for poor force distribution of the forces that arises during child delivery in the perineal area.

Delivery of the foetal head is when it passes through the introitus, i.e. the opening of the vagina. During this process minor or major spontaneous lacerations often occur, giving raise to postpartum discomfort and even long term squeals as anal incontinence. The location of the rupture is usually located at the edge between the posterior wall of the vagina and the perineum (the skin between the vagina and rectum) the so-called commissura posterior. These ruptures can be classified in 4 different levels depending of the extension of the tear, where 1 is superficial and 4 extensive tear into the rectum. When the rectum is involved the anal sphincter is usually injured as well.

Hence, an improved device, and method would be advantageous providing for reduced tissue damage of the mother during childbirth.

Summary of the Invention

Accordingly, the present invention preferably seeks to mitigate, alleviate or eliminate one or more of the above-identified deficiencies in the art and disadvantages singly or in any combination and solves at least the above-mentioned problems by providing a device according to the appended patent claims.

An object of the invention is to diminish the frequency of lacerations during delivery. This may be done in different ways; either by distributing the forces away from the areas liable for rupture or reinforce the same tissue during crowning of the foetal head i.e. when the head of the baby penetrates the vaginal opening. By doing this, the risk of perineal tears diminish and, thus subsequent postpartum complaints. The force on the adjacent area may result in an increased pressure here, but this part is not so stretched because of support of the muscles and pelvic bone and therefore not liable to tears.

According to an aspect a device for reducing tissue damage or ruptures during child delivery is provided. The device comprises a sheet of flexible material, having an upper side and a lower side, wherein at least a part of said lower side in use is in contact with the birth canal wall and said upper side is faced away from the birth canal wall, and wherein the upper side comprises an irregular surface.

Brief Description of the Drawings

These and other aspects, features and advantages of which the invention is capable of will be apparent and elucidated from the following description of

embodiments of the present invention, reference being made to the accompanying drawings, in which

Fig. 1 is a schematic illustration of the posterior part of the introitus vagina called the commissura posterior;

Fig. 2 is a front view of a device according to an embodiment;

Fig. 3 is a back view of a device according to an embodiment;

Fig. 4 is a side view of a device according to an embodiment;

Fig. 5 is a side view of a device according to an embodiment;

Fig. 6 is a schematic side view showing a device according to an embodiment;

Fig. 7 is a cross sectional view of the device according to an embodiment;

Figs. 8 illustrates a cross sectional view of the device according to an embodiment;

Fig. 9 illustrates the device of Fig. 8 at an angle from the lower side towards the middle section according to an embodiment;

Fig. 10 illustrates the device of Fig. 7 at an angle from the upper side towards the middle section;

Fig. 11 illustrates a side view of a device according to an embodiment, in use:

Fig. 12 is front view of the device according to an embodiment;

Fig. 13 is a side-view showing the device according to an embodiment being attached by means of a suture through perineum outside and back into the vagina on the opposite side; Description of embodiments

Several embodiments of the present invention will be described in more detail below with reference to the accompanying drawings in order for those skilled in the art to be able to carry out the invention. The invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The embodiments do not limit the invention, but the invention is only limited by the appended patent claims. Furthermore, the terminology used in the detailed description of the particular embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention.

An object of the invention is to construct a device that protects the tissue in the posterior part of the vaginal opening, called introitus vagina, i.e. the commissura posterior, during child delivery. The origin of perineal tear starts here when the segment is stretched to double or triple its length during delivery of the head. Tears can be more extensive into the perineal body, continue into the anal sphincter and in worse cases even through the whole perineum into the anal canal. In use the device may protect against perineal tears of the posterior vaginal wall into the mucosa, perineal skin, muscles, even more profound down to the anal sphincter muscle and into the rectum and the rectal mucosa. These ruptures are classified in four from I to IV grades depending of the extension of the lacerations.

Accordingly, the device according to all embodiments is configured to distribute the force originating from the baby's head to the commissura posterior during delivery to adjacent areas. In this way the force directed towards the anal sphincter 13 from commissura posterior 14 is distributed evenly along the vaginal wall and hence the load on the commissura posterior is drastically reduced. In confidential experiments made by the inventor pressure recordings have been reduced with 15 % using the device. In a practical implementation the device may be put in place when the foetal head is some cm inside the introitus vagina. Moreover, the device may be put between the posterior part of the foetal head and the posterior vaginal wall.

Fig. 1 is an illustration showing the posterior part of the introitus vagina, called the commissura posterior, which is the location where the tear of the rupture starts, during delivery of the head of the baby. Fig. 1 illustrates the urethral orifice 11, the vagina 12, the anal sphincter 13, commissura posterior 14, perineum 15, and anal sphincter muscle 16. The length of the posterior part of the introitus vagina is doubled or tripled depending of the head circumference and the presentation of the head (occiput anterior or vertex presentation for ex.). Reinforcement or protection of the tissue in the surroundings of commissura posterior would therefore reduce the risk of rupture and subsequently also of worst case scenario, when the anal sphincter muscle, perineal body and the rectal mucosa are involved. The present inventor has conceived that at least two main approaches could be used to protect this region from tears.

The following description focuses on embodiments of the present invention applicable to child delivery and in particular to a device for reducing tissue damage during child delivery.

In an embodiment, according to Fig 2, a device 10 is provided. The device comprises a sheet of flexible material 21. The sheet flexible material has an upper side 22. The upper side 22 comprises at least one portion, e.g. a top section 24, with an irregular surface 22a. The portion comprising the irregular surface 22a is in use configured to be faced towards the child. The pattern of the irregular surface 22a is arranged to guide the child towards the vaginal opening during child delivery with low friction. Hence, in use the upper side is faced towards the baby's dorsal side such that the baby easily may slide over the upper side of the device. The flexible sheet also has a lower side 23 in use configured to be in contact with a first area adjacent to the posterior part of the introitus vagina, such as the perineum, or second area comprising the posterior part of the introitus vagina, such as the birth canal wall or the vaginal opening edge. The sheet is in use formable with the first or second area.

In an embodiment the first area is posterior wall of the lower vaginal canal.

In an embodiment the second area is the perineum.

In an embodiment, as shown in Fig. 2, the irregular surface 22a is wave patterned. The wave pattern comprises grooves 221 extending longitudinally adjacently from the end portion of the top section 24 towards a lower section 25 of the device. The longitudinal direction of the grooves 221 matches the delivery direction of the child during child delivery. During child delivery the head and body of the child moves longitudinally over the longitudinal grooves on its way towards the vaginal opening.

The grooves may be formed by reinforcing the flexible material of the device with reinforcement means 71. The reinforcement means may comprise a number of reinforcement beams, which are more rigid than the surrounding portion of the top section. A function of each reinforcement beam is to stabilize the device during child birth such that the device is prevented from being displaced or folded in use, when the child comes into contact with, and passes the device. Since the head of the baby passes the birth canal with movements going back and forth it is important that the top section has to be non-creasable or non-foldable along its longitudinal direction. Furthermore, a irregular surface 22a having reinforcement beams 71 and grooves 221 is more easily laterally bendable, which enables the top section 24 of the device to better follow the curvature of the birth canal. Hence, each groove 221 in the device may act as a folding line around which the device may be folded.

Accordingly, the device is more easily foldable along the length of the grooves than in a direction perpendicular to the length of the grooves.

In an embodiment the reinforcement means 71 and/or grooves 221 does not necessarily extend all the way up to the edge of the top section 24 as is indicated in Fig. 2 but instead may end before, i.e. at a distance from, the edge of the top section, whereby the edge of the top section remains softer than if the reinforcement means would have extended all the way to the end of the top section 24. Similarly, the reinforcement means 71 and grooves 221 may extend at a distance from the boundary between the lower section 25 and the top section 24 and to the edge of the top section 24 or at a distance from the edge of the top section 24.

The reinforcement beams 71 and/or grooves 221 may be integrated into the flexible material of the top section 24 of the device.

In an embodiment the device comprises a groove 221 positioned along the centreline 291 of the top section 24, as is indicated in Fig. 2. Since a groove 221 is positioned along the centreline 291 the device allows for symmetrical bending or folding around the centreline 291.

At least one groove 221 may be perforated thereby facilitating the ability of folding around the length of the groove 221 , in use.

Furthermore, the design of the grooves 221 analogously allows for cost effective packaging of the device, since the device may be folded into a non-bulky package for transportation or sale.

Fig. 3 illustrates the device of Fig. 2 seen from an opposite angle.

In an embodiment the upper side of the flexible material is provided with a hydrophilic layer or coating (not shown) on its upper side 22. The hydrophilic layer provides for a smooth and slippery surface, facilitating the child during child birth to slide over the upper side 22.

In one embodiment, the hydrophilic layer or coating may be a hydrophilic polymer, such as poly-N-vinylpyrrolidone (PVP), PEO (polyethylene oxide), PEG (polyethylene glycol), or hyaluron. Fat oil like baby-, olive-, sunflower- and other organic oils may also be used.

To improve the attachment of the hydrophilic polymers to the device, aryl ketones, such as benzophenone, may be used as a linker to covalently bind a hydrogel to a polymeric surface when activated by UV irradiation.

The polymer, to which the hydrophilic polymer is attached, may be silicone rubber, polypropylene (PP), polysulfone (PSF), polyvinylchloride (PVC), polystyrene (PS), polyethylene (PE), polycarbonate (PC), polymethylmethacrylate (PMMA), and polyurethane (PU).

Any suitable chemical composition or lubricant for decreasing the level of friction between the device and the child may be applied onto the top section 24 before use.

In an embodiment the lower side 23 of the device is essentially flat. The essentially flat lower side 23 of the device allows for a large contact area towards the birth canal wall in use. Since it is important to provide friction between the device and birth canal wall it is desired that the device and the birth canal wall are suitably attached. The birth canal wall is naturally coated with vaginal secretion. It is desired that a liquid is provided between the device and the birth canal wall to provide for secure attachment between the two. In an embodiment, the vaginal secretion acts as the liquid. Preferably the liquid should have a high surface tension and large adhesive properties in order to attach the device to the birth canal wall.

An adhesive having high surface tension and adhesiveness could e.g. be applied to the lower side 23 of the top section 24 in order to securely attach the device to the birth canal wall, in use. The adhesive may e.g. be glue, e.g. tissue specific glue, creating an attachment of the lower side 23 of the device to the first or second area.

In an embodiment, the liquid or added oil could also act as a glider and therefore facilitate the placement of the device between the head and the posterior vaginal wall in case it is very tight.

In an embodiment the adhesive is selected such that is may attach the lower side 23 of the device to the first or second area, while said first or second area is at least partly covered with body fluids such as, vaginal secretion.

In an embodiment the lower side 23 is provided with a coating (not shown) configured to attach said device to a material in contact with said lower side 23. For example, the coating may be configured such that when it comes in contact with the tissue of the birth canal wall or perineum area it attaches to the respective area, by means of chemical reactions. The attachment further provides for force distribution of the posterior part of the introitus vagina.

The boundary or intersection between the top section 24 and lower section 25 may be referred to as a middle section 28, which is indicated by an arrow in Figs. 2, and 3. The irregular surface 22a may extend and cover at least a part of the middle section 28, as may be observed from Figs. 2 and 3.

The lower section 25 of the device may comprise two flaps 31 , 32 or end sections. The flaps are separate from each other and are each connected to the top section. Hence, each of the flaps follows the curvature of the top section in use. Since the flaps are separate from each other the top section 24 more easily may follow the curvature of the vaginal opening (birth canal) during child delivery. That is of importance since the device is put in place when the vaginal opening is oval, but transforms to a circular shape during crowning of the baby's head. The flaps are during said transformation of the vaginal opening moving towards the centreline 291 due to the expansion of the vaginal opening.

A technical effect of the flaps 31, 32 is that they cover the area between the anal opening and the vaginal opening, thereby reducing the risk of contamination, in use.

A further technical effect of the flaps 31, 32 is that they may be used to keep the device in place in use, e.g. by applying pressure on the flaps 31, 32 using a hand towards the perineum area.

In an embodiment, as may be observed in Figs. 2 and 3, each flap 31, 32 may comprise a marking 27, indicating suitable pressure points for keeping the device in place, in use. During use the attending health care personnel may use two fingers, such as the thumb and index finger, to manually decrease the tensions on the commissura posterior by pressing the openings towards each other. Moreover, the markings may be used for correction of location and insertion of the device. Another advantage of using a lower section design as in Fig. 3 is that as there is no material between the two end sections, the device is more easily bent over the edge at the vaginal opening. This is due to the fact that when bending the device around the edge at the vaginal opening the lower section of the device will extend or expand. Moreover, the upper part of the lower section closest to the middle section 28 will have to expand to a lesser degree than lower part of the lower section due to the fact that the vaginal opening is circularly shaped. Accordingly, by providing the device with flaps 31, 32 unnecessary material tension is avoided and a better fit is achieved. Moreover, this embodiment further reduces the tension forces on the commissura posterior.

In an embodiment the flaps 31, 32 overlaps (not shown) each other in the idle state of the device. As the middle section 28 follows the curvature of the vaginal opening, by means of folding around the centrelines 291 if the grooves 221, in use, the flaps also rotate around the centrelines 291, whereby the distance between one point at the first flap and one point at the second flap 32, varies. Hence, when the vaginal opening is small, i.e. radii of the vaginal opening is small, such as in the beginning of the child delivery, the distance between the two points of the flaps will be higher than when the radii of the vaginal opening is larger, such as towards the end of the child delivery procedure. The overlapping of the flaps in the idle state of the device enables the technical effect that the vaginal opening may be protected from contamination e.g. from the anal opening since the flaps 31, 32 acts as a blocking sheet even for different curvatures of the vaginal opening edge. Hence the overlapping flaps 31, 32 efficiently protect the vaginal opening from contamination during the whole child delivery procedure.

Device materials

In an embodiment the device is made of a flexible material. The flexible material of the device according may be elastic and is thus able to follow the transformation of the birth canal during delivery. This means that the sheet is formable. Accordingly, the device may change in shape throughout the child delivery process due to its elastic features. Thus, it may be extended along the vaginal opening edge as the vaginal opening expands during the child delivery counteracting the vaginal opening expansion forces at the posterior part of introitus vagina by its intrinsic force features of returning to its equilibrium state, thereby providing force distribution around commissura posterior.

The device could be made of tissue/textiles that are adaptable to dynamic transformation of the vaginal wall.

The flexible material may e.g. polymeric material suitable to be used for medical applications. The flexible material may e.g. be polypropylene, polyethylene, polyurethane, polycarbonate, vinyl, polytetrafluoreten, silicon etc.

According to some embodiments the flexible material is transparent making possible a continuous inspection of the tissue. Textiles of different origin can be used. The variety is numerous but the importance is that the substances give support to the tissue and that allergic reactions are not triggered. However, the material of the device is not limited to only polymeric materials, and accordingly any polymeric or non- polymeric such as metallic flexible material may be used, respectively or in

combination.

The flexible material may be configured as a plate, with or without

perforations.

The device according to some embodiments is shaped to protect the outer part of the vagina and some cm beyond the commissura posterior of the perineum. Fig. 2 illustrates a device shape according to an embodiment. However, depending on anatomical differences between patients other shapes are equally possible to use. The passage of the head may proceed since the device is thin and does not interfere with the progress of the delivery. After delivery the device may be removed when its protective effect has been accomplished.

The device may be of different shapes as well as sizes and flexible materials. The shape of the device may be made in different sizes depending of the anatomy of the birth canal and clinical results. For example, it may cover a distance, e.g. 4-6 cm of the commissura posterior up on the posterior wall of the vagina as protecting the adjacent perineum. Size, shape, form and material can be combined in different combinations together or separately.

According to en embodiment, the top section 24 in use extends 4 to 9 cm, such as 4, 5, 6, 7, 8 cm inside the inside the vaginal opening.

In an embodiment the device is thin, such as having a maximum thickness of 5 mm, such as 1 mm. The thickness of the device may differ over the device. In an embodiment the top section or middle section is 0,1 to 1 mm. In an embodiment the end section is over 1 mm, such as 2 mm. In this way the device does not interfere with passage of the head of the baby in the delivery canal.

The reinforcement beams 71 may be made of a material having a higher stiffness than the flexible material. Different materials may be used for reinforcement beam 71. However, the material of the reinforcement means having a higher stiffness than the flexible material may in fact comprise the same material as the flexible material, but having higher concentration or compactness, making the material of the reinforcement means stiffer than the flexible material.

Middle section 28 Figs. 4 and 5 illustrate the device according to an embodiment, seen from two opposite side views, in an idle or relaxed state.

In Fig. 4 the top section 24 and the lower section 25 both extends from the middle section 28 in essentially the same direction, forming a device having a U-shape form when observed from a side view in its idle state. The base of the U-shape constitutes the middle section 28. The irregular pattern 22 further improves the stability of the U-shape. Due to the intrinsic character of the device, it strives to return to its original idle U-shape configuration.

Fig. 6 illustrates a simple sketch of the device, seen from a side view when the top section 24 and the lower section 25 has been somewhat separated, e.g. during insertion of the top section 24 into the vaginal opening. The arrows in Fig. 6 indicate the intrinsic passive forces of the device, when bent. In use, when the top section 24 is placed in the posterior part of the introitus vagina, and the end section 25 is placed outside the birth canal, the passive forces act to hold the underlying tissue together, thereby reducing the risk of tears or ruptures during the child delivery.

As may be seen in Figs. 4 and 5 the middle section 28 may comprise reinforcement beams 71 (optionally the same as are provided in the top section) to improve the stability and increase the intrinsic forces in its longitudinal direction. When bent the reinforcement beam 71 due to its intrinsic character strives to return to its original configuration. Thus, when bending the reinforcement beam 71, due to the intrinsic character, passive forces, indicated by arrows in Fig. 6, counteract the bending. These passive forces contribute to the force distribution of the device during child delivery, since they indirectly act to keep the tissue, to which the middle section 28 is in contact, together.

The middle section 28 may also comprise grooves 221 to facilitate folding in lateral direction, such that the middle section may be easily formed along the curvature of the vaginal opening edge.

In an embodiment the angle between the plane of the top section 24 and the lower section 25 is less than 90 degrees, in the device's idle state.

In an embodiment the angle between the plane of the top section 24 and the lower section 25 is approximately 20 degrees, in the device's idle state.

In an embodiment the angle between the plane of the top section 24 and the lower section 25 is between 10 degrees and 30 degrees, in the device's idle state. Fig. 7 illustrates a cross sectional view of the device according to an

embodiment, in which the top section has been removed for visual purposes. In Fig. 7, a part of the middle section 28, may be observed in greater detail.

Fig. 8 illustrates a cross sectional view of the device according to an

embodiment, in which the top section has been removed for visual purposes. Each flap 31, 32 comprises a recess portion 311, 321. The recess portion 311, 321 provides for the technical effect that it indicates a position at which the attending health care personnel may apply manual pressure during the child delivery.

In Fig. 8 the curvature of the middle section 28 has a radius of approximately 60 mm. Fig. 8 illustrates the device from a view towards the perineum of the patient, in use. The radius is based on the fact that the mean circumference of the baby's head is normally 36 cm (+ 4 cm) which gives a circle with an approximate radius of 60 mm. For example, if the baby's head has a circumference of 32 cm the radius of the curvature of the middle section is approximately 51 mm. In the event that the baby's head has a circumference of 40 cm the radius of the curvature of the middle section 28 is approximately 64 mm. In the event that the baby's head has a circumference of 36 cm the radius of the curvature of the middle section 28 is approximately 58 mm. The device assumes this approximate curvature at its middle section 28 when the baby's head passes the vaginal opening.

The width of the middle section may vary between approximately 2 cm to 8cm, mainly depending on the physical anatomy of the patient. However, from a force distribution perspective it is better for the middle section 28 to be as wide as possible. In an embodiment the width of the middle section 28 is approximately 4 cm, or 5 cm or 6 cm or 7 cm or 8 cm. However, the width may also be 2 cm, or 2, 5 cm, or 3 cm, or 3,5 cm, or 4 cm, or 4,5 cm, or 5 cm or 5,5 cm, or 6 cm, or 6, 5 cm, or 7 cm, or 7,5 cm or 8 cm.

Fig. 9 illustrates the device of Fig. 8 at an angle from the lower side 23 towards the middle section 28, i.e. when the device is observed in extended mode from beneath, e.g. towards the vagina and perineum.

Fig. 10 illustrates the device of Fig. 7 at an angle from the upper side 22 towards the middle section 28. Fig. 10, as well as Figs. 3, 7, 8, 9, illustrates how the flaps may be separated, e.g. in form of a slit 72, i.e. the area between the flaps 31, 32, which in use lie against the perineum. The slit may extend between the flaps 31, 32 up until the top section 24. This improves the lateral foldability of the device in use.

Moreover, the slit 72 allows for visual inspection of the area between the vaginal opening and the rectum. When the tension on this area increases, during child delivery, the area becomes increasingly white, which indicates that the risk of rupture has increased.

According to an embodiment, a separate or integral membrane, preferably transparent for inspection purposes, may be placed between the lower section (25) of the device 10 and the perineum in use, in order to protect the vaginal canal from

contamination from e.g. the rectum. The membrane may be integral (not shown) with the middle section (28) of boundary between the middle section (28) and the top section (24), e.g. in at least one point.

Fig. 11 illustrates a side view of the position of the device during childbirth.

The baby's head 51 with the little fontanel 52 and large fontanel 53 will exert a force downwards towards the device 10 and protect the commissura posterior 14.

Fig. 12 illustrates the device according to an embodiment, in use. In Fig. 12, the arrows indicate the passive forces, due to the intrinsic character of the device, when the device is bent along the vaginal opening edge. The effect of the passive forces is that the underlying tissue is held together and stabilized, thereby reducing the risk of tears of ruptures during child delivery.

By means of the intrinsic forces of the device, when the device is placed in the vaginal and perineal part in use, the device will exert the intrinsic forces onto the underlying tissue, thereby compressing and stabilizing the posterior vaginal wall and the perineum, in use. Fig. 13 is a cross sectional side view of the device in use, wherein the arrows indicate the at least some of the intrinsic forces of the device.

The device for reducing the tension of the tissue and tears during child delivery may be used separately, or in conjunction with other common child delivery devices Although the present invention has been described above with reference to specific embodiments, it is not intended to be limited to the specific form set forth herein. Rather, the invention is limited only by the accompanying claims and, other embodiments than the specific above are equally possible within the scope of these appended claims.

In the claims, the term "comprises/comprising" does not exclude the presence of other elements or steps. Furthermore, although individually listed, a plurality of means, elements or method steps may be implemented by e.g. a single unit or processor. Additionally, although individual features may be included in different claims, these may possibly advantageously be combined, and the inclusion in different claims does not imply that a combination of features is not feasible and/or advantageous. In addition, singular references do not exclude a plurality. The terms "a", "an", "first", "second" etc do not preclude a plurality. Reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.

Claims

1. A device (10) for reducing tissue damage or ruptures during child delivery, comprising

a sheet (21) of flexible material, having an upper side (22) and a lower side

(23), wherein at least a part of said lower side (23) in use is in contact with the birth canal wall and said upper side (22) is faced away from the birth canal wall, and wherein the upper side (22) comprises an irregular surface (22a).

2. The device (10) according to claim 1, wherein the device (10) comprises a top section (24), which in use is to be inserted into the vaginal opening, wherein the top section (24) at least partly comprises the irregular surface (22a).

3. The device (10) according to claim 1, wherein the irregular surface (22a) is configured to guide the child towards the vaginal opening during child delivery with low friction.

4. The device (10) according to any one of the previous claims, wherein the irregular surface (22a) is wave patterned.

5. The device (10) according to any one of the previous claims, wherein irregular surface (22a) comprises at least one groove (221) along which the device (10) may be folded, and a reinforcement beam (71) which is more rigid or stiff than the flexible material along its longitudinal direction.

6. The device (10) according to claim 5, wherein the reinforcement beam (71) is integral with the flexible material.

7. The device (10) according to claims 5 or 6, wherein a groove (221) is positioned along the centreline (291) of the top section (24).

8. The device (10) according to any one of the claims 5 to 7, wherein at least one groove (221) is perforated.

9. The device (10) according to any one of the previous claims, wherein the upper side (22) is provided with a hydrophilic layer, coating or lubricant.

10. The device (10) according to any one of the previous claims, wherein the upper side (22) is provided with a hydrophilic layer or coating.

11. The device (10) according to any one of the previous claims, wherein the lower side (23) is essentially flat.

12. The device (10) according to any one of the previous claims, wherein the lower side (23) of the top section (24) in use attaches to the birth canal wall by means of a liquid having a suitable surface tension and suitable adhesive properties.

13. The device (10) according to claim 12, wherein the liquid constitutes the vaginal secretion.

14. The device (10) according to claim 12, wherein the liquid constitutes a combination of a further liquid, such as an adhesive, and the vaginal secretion.

15. The device (10) (10) according to claim any one of the previous claims, wherein the device (10) comprises a lower section (25), which in use is configured to be situated outside the vaginal opening towards the perineum.

16. The device (10) according to claim 15, wherein the device (10) comprises a middle section (28) located between the top section (24) and the lower section (25) of the device (10).

17. The device (10) according to claim 16, wherein the irregular surface (22a) extends over and covers at least a part of the middle section (28).

18. The device (10) according to any one of the claims 15 to 17, wherein the lower section comprises two flaps (31, 32).

19. The device (10) according to claim 18, wherein the flaps (31, 32) are separate from each other and are each connected to the top section (24) or middle section (28).

20. The device (10) according to claim 18 or 19, wherein at least one of the flaps (31, 32) comprises a marking (27) indicating suitable pressure points at which the attending nurse of doctor may apply manual pressure e.g. by a hand or finger.

21. The device (10) according to any one of claims 18 to 20, wherein the two flaps (31, 32) each other in an idle state of the device (10).

22. The device (10) according to any one of the previous claims, wherein the flexible material is at least partly transparent.

23. The device (10) according to any one of the claims 2 to 22, wherein the top section (24) in use extends 4 to 9 cm, such as 4, 5, 6, 7, 8 cm inside the vaginal opening.

24. The device (10) according to any one of the claims 2 to 22, wherein the flexible material has a maximum thickness of about 5 mm, such as 0,5, 1, 1,5, 2, 2,5, 3, 3,5, 4, 4,5, or 5 mm.

25. The device (10) according to any one of the previous claims, wherein the flexible membrane or irregular surface (22a) has intrinsic forces which strives to return to the idle state configuration of the device (10).

26. The device (10) according to any one of the previous claims, wherein the device (10) is U-shaped in its idle state.

27. The device (10) according to any one of the previous claims, wherein the angle between the top section (24) and the lower section (25) is less than 90 degrees, in the device's idle state, such as 10 degrees to 30 degrees, such as 20 degrees.

28. The device (10) according to any one of the claims 18 to 27, wherein the at least one flap (31, 32) comprises a recess portion (311, 321).

29. The device (10) according to any one of the claims 18 to 28, wherein the flaps (31 , 32) are separated by a slit (72).

30. The device (10) according to any one of the claims 16 to 29, wherein the width of the middle section (28) is between 2 cm and 8cm, such as 2 cm, or 2, 5 cm, or 3 cm, or 3,5 cm, or 4 cm, or 4,5 cm, or 5 cm or 5,5 cm, or 6 cm, or 6, 5 cm, or 7 cm, or 7,5 cm or 8 cm.

31. The device (10) according to any one of the claims 1 to 30, wherein the device comprises at least two reinforcement beams each having a higher stiffness than the flexible material of the sheet (21).